Acute Deep Vein ThrombosisNCT00480636

Fragmin In The Treatment Of Acute Deep-Vein Thrombosis With Or Without Pulmonary Embolism In Cancer Patients

An observational study of Acute Deep Vein Thrombosis, run by Pfizer.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

To collect postmarketing data about Fragmin safety and efficacy in the treatment of deep vein thrombosis with or without pulmonary embolism in cancer patients. Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Acute Deep Vein Thrombosis
What is being tested?: Fragmin (dalteparin sodium )
How many people: 102 participants
Where: No sites listed yet
Study dates: Jun 2007to Jun 2009
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Study population: The patients are identified in primary care setting.

Who may be able to join

Male or female patient of 18 - 70 years of age.
Cancer patient with proven deep-vein thrombosis with or without pulmonary embolism confirmed by combination of clinical signs and symptoms, pulmonary hypertension on echocardiogram, X-ray examination of the lung and eventually perfusion/ventilation scan of the lung.

Who cannot join

Bleeding
Hypersensitivity to FRAGMIN® or other low-molecular weight heparins.
Serum creatinine level > 150 umol/l.
Platelet count of less than 100 000 per cubic millimeter at the beginning of the therapy.
Patient on oral anticoagulation therapy in the last 7 days.

About this study

Official title: Fragmin Safety And Efficacy In The Treatment Of Acute Deep-Vein Thrombosis With Or Without Pulmonary Embolism And Extended Thromboprophylaxis In Cancer Patients In Slovakia (An Open, Prospective, Non-Comparative Study)

To collect postmarketing data about Fragmin safety and efficacy in the treatment of deep vein thrombosis with or without pulmonary embolism in cancer patients.

Read the detailed description

Method: consecutive patient sampling. Patients were (are) included in the study in consecutive manner if they fulfilled the inclusion criteria and any of the exclusion criteria were not present.

Conditions: Acute Deep Vein Thrombosis
Being tested: Fragmin (dalteparin sodium )

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Fragmin (dalteparin sodium )Drug
Also called Fragmin
Month 1: dalteparin 200 IU/kg SC once daily. Months 2-6: dalteparin 150 IU/kg SC, once daily.

Study groups in NCT00480636
Study group	Role	What they receive
One cohort of patients treated with dalteparin.		About 100 patients with deep-vein thrombosis and with or without pulmonary embolism will be included in the study. Receives: Drug: Fragmin (dalteparin sodium )

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Resolution of Deep Vein Thrombosis (DVT) of the Leg
Resolution criteria: clinical cure, defined as negative results of a compressive ultrasound examination of the leg
Measured: Month 6 or End of Treatment (EOT) (up to Month 6)

Secondary outcomes (4)

Number of Participants With Severe Bleeding That Resulted in a Transfusion of at Least 2 Units of Blood
Episodes of the severe bleeding (intracranial, intraspinal, intraocular, retroperitoneal, or in pericardial area) or bleeding from gastrointestinal (GIT), urinary system or gynecological bleeding resulted in a need for a transfusion of at least 2 units of blood. Subjects were assessed for severe bleeding as part of a systematic adverse event assessment.
Measured: Baseline through Month 6 or EOT (up to Month 6)
Number of Participants With Severe Bleeding That Resulted in a Decrease in Hemoglobin Level of at Least 2.0 Grams Per Deciliter (g/dL)
Episodes of the severe bleeding (intracranial, intraspinal, intraocular, retroperitoneal, or in pericardial area) or bleeding from GIT, urinary system or gynecological bleeding which led to a drop of hemoglobin of at least 2.0 g/dL. Subjects were assessed for severe bleeding as part of a systematic adverse event assessment.
Measured: Baseline through Month 6 or EOT (up to Month 6)
Percent of Participants With and Without Pulmonary Embolism (PE)
PE (diagnosed on the basis of ventilation-perfusion scan of the lungs or autopsy)
Measured: Baseline, Week 2, Month 1, Month 3, and Month 6 or EOT (up to Month 6)
Number of Participants With Recurrent DVT
Defined as the number of participants with recurrence of DVT (diagnosed using compressive ultrasound examination or autopsy) after it has resolved (at the same location) or occurrence of new DVT at a new location on any of the post-baseline visits
Measured: Month 6 or EOT (up to Month 6)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2007Jun 2009

First posted31 May 2007 (estimated)
Study startJun 2007
Primary completionJun 2009
Study completionJun 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Acute Deep Vein ThrombosisStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 102 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00480636
Sponsor's protocol ID: A6301082
Status last verified: Jul 2010
First submitted: 29 May 2007
Last updated: 10 Aug 2010
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Recruiting
PROfunda Femoris Vein Thrombosis Evaluation and Clearance to Improve Outcomes of Endovascular Treatment for Acute Iliofemoral Deep Vein Thrombosis
Deep Vein Thrombosis
RecruitingPhase 2
Perivenous Dexamethasone Therapy: Examining Reduction of Inflammation After Thrombus Removal to Yield Benefit in Acute Femoropopliteal DVT
Thrombosis, Deep Vein, Iliofemoral; Thrombosis
Enrolling by invitationObservational study
Multimodal Physiologic State Intelligence Study
Heart Failure, Cardiomyopathies
Recruiting
DVT Burden and the Risk of Post-thrombotic Syndrome
Postthrombotic Syndrome
Not yet recruitingObservational study
Prospective Cohort of Acute Cardiology Referrals in an Ambulatory Day-Hospital Setting
Acute Coronary Syndromes, Heart Failure

All Acute Deep Vein Thrombosis trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Fragmin Safety And Efficacy In The Treatment Of Acute Deep-Vein Thrombosis With Or Without Pulmonary Embolism And Extended Thromboprophylaxis In Cancer Patients In Slovakia (An Open, Prospective, Non-Comparative Study)
ClinicalTrials.gov ID: NCT00480636
Acronym / sponsor ID: A6301082
Conditions: Acute Deep Vein Thrombosis
Study type: Observational
Recruitment status: Completed
Enrolment: 102 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Jun 2007
Primary completion: Jun 2009 (actual)
Study completion: Jun 2009 (actual)
First posted: 31 May 2007 (estimated)
Results: Posted 10 Aug 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

To collect postmarketing data about Fragmin safety and efficacy in the treatment of deep vein thrombosis with or without pulmonary embolism in cancer patients.

Detailed description

Method: consecutive patient sampling. Patients were (are) included in the study in consecutive manner if they fulfilled the inclusion criteria and any of the exclusion criteria were not present.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
One cohort of patients treated with dalteparin.	–	Drug: Fragmin (dalteparin sodium )About 100 patients with deep-vein thrombosis and with or without pulmonary embolism will be included in the study.

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: The patients are identified in primary care setting.

Key inclusion criteria (2 listed)

Male or female patient of 18 - 70 years of age.
Cancer patient with proven deep-vein thrombosis with or without pulmonary embolism confirmed by combination of clinical signs and symptoms, pulmonary hypertension on echocardiogram, X-ray examination of the lung and eventually perfusion/ventilation scan of the lung.

Key exclusion criteria (5 listed)

Bleeding
Hypersensitivity to FRAGMIN® or other low-molecular weight heparins.
Serum creatinine level > 150 umol/l.
Platelet count of less than 100 000 per cubic millimeter at the beginning of the therapy.
Patient on oral anticoagulation therapy in the last 7 days.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Fragmin (dalteparin sodium )Also: FragminMonth 1: dalteparin 200 IU/kg SC once daily. Months 2-6: dalteparin 150 IU/kg SC, once daily.	Drug	One cohort of patients treated with dalteparin.

Primary outcome

Number of Participants With Resolution of Deep Vein Thrombosis (DVT) of the Leg
Time frame: Month 6 or End of Treatment (EOT) (up to Month 6)
Resolution criteria: clinical cure, defined as negative results of a compressive ultrasound examination of the leg

4 secondary outcomes

Number of Participants With Severe Bleeding That Resulted in a Transfusion of at Least 2 Units of Blood
Time frame: Baseline through Month 6 or EOT (up to Month 6)
Number of Participants With Severe Bleeding That Resulted in a Decrease in Hemoglobin Level of at Least 2.0 Grams Per Deciliter (g/dL)
Time frame: Baseline through Month 6 or EOT (up to Month 6)
Percent of Participants With and Without Pulmonary Embolism (PE)
Time frame: Baseline, Week 2, Month 1, Month 3, and Month 6 or EOT (up to Month 6)
Number of Participants With Recurrent DVT
Time frame: Month 6 or EOT (up to Month 6)

Results and safety

Results posted to the registry on 10 Aug 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Dalteparin	102	83

Primary outcome: Number of Participants With Resolution of Deep Vein Thrombosis (DVT) of the Leg

Time frame: Month 6 or End of Treatment (EOT) (up to Month 6). Number. Unit: Participants

Measure	Dalteparin n = 102
Value	43

Population analysed: Full analysis set (FAS): all participants who received at least 1 dose of the study treatment and who had at least 1 post baseline efficacy measurement.

4 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Dalteparin	13 of 102 (12.7%)	0 of 102 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2010.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

Related trials for Acute Deep Vein Thrombosis

Recruiting
PROfunda Femoris Vein Thrombosis Evaluation and Clearance to Improve Outcomes of Endovascular Treatment for Acute Iliofemoral Deep Vein Thrombosis
Deep Vein Thrombosis
RecruitingPhase 2
Perivenous Dexamethasone Therapy: Examining Reduction of Inflammation After Thrombus Removal to Yield Benefit in Acute Femoropopliteal DVT
Thrombosis, Deep Vein, Iliofemoral; Thrombosis
Enrolling by invitationObservational study
Multimodal Physiologic State Intelligence Study
Heart Failure, Cardiomyopathies
Recruiting
DVT Burden and the Risk of Post-thrombotic Syndrome
Postthrombotic Syndrome
Not yet recruitingObservational study
Prospective Cohort of Acute Cardiology Referrals in an Ambulatory Day-Hospital Setting
Acute Coronary Syndromes, Heart Failure

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

Questions about this trial

What is this clinical trial studying?

An observational study of Acute Deep Vein Thrombosis, run by Pfizer.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Aug 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Resolution of Deep Vein Thrombosis (DVT) of the Leg (time frame: Month 6 or End of Treatment (EOT) (up to Month 6)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00480636.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2010.